Method and system for reduction of contamination in needle guides

ABSTRACT

A system and method for reducing the risk of contamination of interior regions of a needle guide which is disposed on an endocavity transducer, which system includes an elastic membrane forming a pocket which covers a needle exit hole in the needle guide. The pocket is disposed on a sheath which is both; disposed around the endocavity transducer and between the endocavity transducer and the needle guide.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of the non-provisionalpatent application having the Ser. No. 13/446,788 filed Apr. 13, 2012,which application claims the benefit of the filing date of theprovisional patent application having Ser. No. 61/476,069 filed Apr. 15,2011, the contents of which are incorporated herein in their entirety bythis reference.

FIELD OF THE INVENTION

The present invention generally relates to medical equipment, and moreparticularly relates to medical equipment which must be covered with asheath during medical procedures, and even more particularly relates tomethods and systems for reducing contamination of interior spaces of aneedle/cannula guide when disposed outside of a sheath around anendocavity transducer.

BACKGROUND OF THE INVENTION

In recent years, medical professionals have used various types of biopsysystems to collect tissue from internal regions of the body. Thesebiopsy systems are typically either enclosed in a sterile disposablesheath prior to use on any patient, or they are cleaned after use. Thebiopsy system or transceiver may be a mechanical or electro-mechanicaldevice. Often a sheath is placed over the biopsy system and then aneedle/cannula guide is coupled to the biopsy system but on the outsideof the sheath. In such configurations, the needle guide is not protectedby the sheath.

When the sheath covered system with an externally mounted needle guideis inserted into a rectal or vaginal cavity or surgical incision,contaminants may enter and contaminate internal sections of the needleguide. It is well known to use a second sheath to cover the entirecombination including the previously externally mounted needle guide.

While such double sheath procedures have been used extensively in thepast, the doubling of these sheaths doubles the sheath cost and is moretime consuming and, therefore, even more costly.

Consequently, there exists a need for improved methods and systems forprotecting internal sections of needle guides mounted to sheath coveredbiopsy systems in an efficient manner, while simultaneously maintainingthe sterile or aseptic state of the internal spaces in the needle guidewhen portions of the entire combination are inserted into a body cavity.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a system and methodfor covering portions of needle guides which are mounted to sheathcovered biopsy systems in an efficient manner.

It is a feature of the present invention to utilize a sterile hole coverwhich is configured to cover an otherwise exposed needle or cannula exithole in an externally mounted needle guide.

It is another feature of the present invention to include a relativelysmall adhesive needle hole cover.

It is an advantage of the present invention to provide reduced abilityfor contamination to enter inside a needle guide when it is insertedinto a body cavity.

It is another advantage of the present invention to reduce cost forprotecting needle guides which are not covered by a sheath.

The present invention is an apparatus and method for covering exitneedle holes for needle guides for use with biopsy systems designed tosatisfy the aforementioned needs, provide the previously stated objects,include the above-listed features, and achieve the already articulatedadvantages. The present invention is carried out in a “wasted time-less”manner in a sense that the time consumed, in adding a second full sheathover the needle guide, has been eliminated. The invention is alsoaccomplished in a “tear-less” or “contamination-less” manner in thesense that the contamination that may be exposed to the internal areasof the needle guide through a tear in a outer sheath of a double sheatharrangement, after a needle is caused to exit the inside of the outersheath, has been reduced.

Accordingly, the present invention is a system and method including aself-sealing needle or cannula exit hole cover for use on a needle guidemounted outside of any sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more fully understood by reading the followingdescription of the preferred embodiments of the invention, inconjunction with the appended drawings wherein:

FIG. 1 is an exploded perspective view of the contamination reducingsystem of the present invention, which shows a needle guide with adetached exit hole cover.

FIG. 2 is a perspective view of the contamination reducing system ofFIG. 1, which shows a needle guide with an attached exit hole cover,where the dotted line shows the now covered exit hole.

FIG. 3 is a perspective view of the present invention attached to asheath covered biopsy system.

FIG. 4 is a perspective view of the contamination reducing system of thepresent invention, which shows a needle guide with attached terminalboot, where the dotted line shows the now covered exit hole.

FIG. 5 is a perspective view of the contamination reducing system of thepresent invention with a terminal boot which is integrated into a pocketat the end of a sheath, where the dotted line shows the now covered exithole.

DETAILED DESCRIPTION

Now referring to the drawings wherein like numerals refer to like matterthroughout, and more specifically referring to FIGS. 1 and 2, there isshown a needle guide system of the present invention generallydesignated 10, which includes a needle or biopsy cannula guide 200, ofthe prior art, which can be similar to many different prior art needleguides especially those having an elongated central section 340 which isconfigured to have a rear or proximal portion 330 thereof remain outsideof the body when the front or distal portion 320 is inserted into thebody orifice near the tissue to be penetrated by the needle or biopsycannula. The guide 200 is attached to the ultrasound transducer 100, butonly after the ultrasound transducer is covered with a sheath 150.

The present invention is a method and system for protecting the insideof the needle guide from contamination without the use of a completesecond sheath.

Instead, a relatively small membrane 300 is disposed over a needle orcannula exiting hole 310 (shown with dashed lines in FIG. 2) on thefront end 320 of the needle guide 200, this membrane 300 covers the exithole 310 of the needle guide 200 so that when it is inserted into apatient there is no contamination entering the inside of the needleguide 200 via the exit hole 310. When the transducer 100, withassociated sheath 150 and attached needle guide 200 is inserted into therectal or vaginal cavity, a needle is then pressed through the membrane300 into the patient's tissue. The needle pierces the membrane 300 but,in one embodiment, the membrane 300 while remaining attached to theneedle guide 200, also clings to the needle or biopsy cannula so as toreduce contamination from entering the inside of the needle guide 200.

The membrane 300 can be a small piece of material similar to that usedfor sheaths or other suitable materials. The membrane 300 may be held inplace by an adhesive which bonds with the outside of the needle guide200. The membrane can also be welded to the needle guide 200. Ideallythe membrane 300 is an elastic material, but any material could be used.For example, regular transparent tape placed over the needle exit hole310 of a needle guide 200 could be a very crude example of a membrane300. When the needle or cannula 400 is removed from the patient andretracted into the needle guide 200, the membrane 300 may cling to theneedle and reduce contaminants from being drawn into the needle guide200 on the exterior of the needle.

The membrane 300 however, in one embodiment, will specifically excludeany type of cover which covers any substantial portion of the transducer100 so as to provide substantial shielding (either primary or secondaryredundant shielding) of the transducer 100 from contaminants.Additionally, the membrane 300, in one embodiment, shall not include anymaterial which covers substantially all of the needle guide 200. Inanother embodiment, the membrane 300 might cover the entire needle guide200.

The membrane 300 can also be used to detect whether the guide 200 hasbeen previously used, in such cases the membrane will be broken.

In one embodiment, the membrane 300 can be used on numerous differenttypes of needle guides. In another embodiment, the membrane 300 may becustom fit for a particular needle guide.

The membrane 300 in one embodiment could be attached by the physician orother medical imaging professional before the insertion of the needleguide 200 into the patient. In another embodiment, the membrane 300could be attached to the needle guide 200 by the manufacturer or otherassembly, inspection or certification personnel.

Now referring to FIG. 4, there is shown an embodiment of the presentinvention which utilizes a boot 400, instead of the membrane 300, ofFIGS. 1-3. Boot 400 may extend over the exit hole 310 and also extendaround the entire front or distal end of needle guide 200. The materialand method of attachment of boot 400 can be similar to membrane 300. InFIG. 4, the boot 400 is separate from the sheath 150 and may be attachedto the needle guide 200 by the physician or by the manufacturer or otherpersonnel.

Now referring to FIG. 5, there is shown a system of the presentinvention where the boot 400 of FIG. 4 is incorporated into an exteriorpocket 500, which is located on sheath 550. Sheath 550 may be similar tosheath 150 except for the pocket 500 and the boot 400. In an alternateembodiment, the combination of the pocket 500 and the exterior of thesheath 550 adjacent to the pocket 500 may essentially form a boot whichfunctions much like boot 400 of FIG. 4.

In operation, the apparatus and method of the present invention asdescribed in FIGS. 1-3 could function as follows: the biopsy system 100is covered with a sheath 150 and then a needle guide 200 is attachedthereto on the exterior of the sheath 150, the combination of the biopsysystem 100, sheath 150 and needle guide 200 (with membrane 300 attachedthereto) is inserted into a body cavity of a patient. When the distalportion of the biopsy system 100 and the distal portion of needle guide200 are inside the body cavity, the needle is inserted into the proximalend 330 of needle guide 200 and passes through an intermediate channelor cannula 342 and then the needle is manipulated from the proximal end330 of the needle guide 200. Tissue may be removed from the patient viathe needle/cannula and retracted from the needle guide 200 which is alsoremoved from the patient. The boot 400 would function very similarly tothe system with membrane 300.

The pocket 500 would work very similarly except that the distal end ofthe needle guide would be covered by the boot 400 or pocket 500 byinserting the distal end of the needle guide into the boot 400 or pocket500, which is already attached to sheath 550, which has already beendisposed over the biopsy system 100.

Throughout this description, reference is made to sterile or a sterilesheath or other sterile items. It should be understood that this couldrefer to any state of cleanliness with respect to living organisms or amedia upon which living organisms could grow. The present invention isintended to cover items that are aseptic, as well as sterile.

Throughout this description, reference is made to a physician. Thepresent invention is intended to apply to any person, such as, but notlimited to, physicians, physicians' assistants, nurses, medical imagingspecialists, veterinarians, veterinarians' assistants, industrial cleanroom technicians, etc.

Throughout this description, reference is made to a biopsy system orother medical equipment. The present invention may be applicable to anyenvironment, such as, but not limited to, medical, veterinary or cleanroom applications, etc.

Throughout this description the term needle is used to refer to anelongated object that enters a patient's tissue, it should be understoodthat this term is intended to refer to cannulas as well as needles.Similarly the term needle guide as used herein is intended to refer tocannula guides, which are capable of guiding cannulas.

It is thought that the method and apparatus of the present inventionwill be understood from the foregoing description and that it will beapparent that various changes may be made in the form, construct steps,and arrangement of the parts and steps thereof, without departing fromthe spirit and scope of the invention or sacrificing all of theirmaterial advantages. The form herein described is merely a preferredexemplary embodiment thereof.

We claim:
 1. A system for protecting inside surfaces of a needle guide,from contamination entering through a needle exit hole of the needleguide, the system comprising: an endoscope imaging device having adistal endoscope end configured to be inserted inside a body cavity of ahuman, a proximal endoscope end configured to remain outside the bodycavity; a needle guide configured to be directly disposed on, supportedby and directly coupled to and partially enshroud an exterior surface ofsaid endoscope imaging device, said needle guide having a distal end anda proximal end and a needle exit hole therein distal of said proximalend, said needle exit hole having a needle exit hole radius, which has aneedle exit hole perimeter dimension; an intermediate linear channel isdisposed between the needle exit hole and the proximal end; saidintermediate linear channel is sized and configured so the said proximalend remains outside the body cavity; said distal end disposed inproximity to said distal endoscope end; said needle exit hole and saidintermediate linear channel are configured to allow a needle or cannulawhich is inserted into the proximal end of the needle guide to exit theneedle guide; a disposable piece of previously rolled adhesive membrane,with a disposable piece of previously rolled adhesive membrane perimeterdimension which is larger than said needle exit hole perimeterdimension, said disposable piece of previously rolled adhesive membraneonly contacts an engagement zone, having an engagement zone outerperimeter dimension, which is larger than said needle exit holeperimeter dimension, said engagement zone located only on an externalneedle guide surface of said needle guide and only around a periphery ofsaid needle exit hole, where said disposable piece of previously rolledadhesive membrane extends completely over said engagement zone andcompletely covers said needle exit hole and said disposable piece ofpreviously rolled adhesive membrane is not configured to contact anexterior portion of an endoscope imaging device; wherein said disposablepiece of previously rolled adhesive membrane contacts only anin-substantial amount of the external surface area of said needle guide;and wherein a layered configuration exists beginning with said exteriorportion of said endoscope imaging device; a portion of the needle guide,and the disposable piece of previously rolled adhesive membrane.
 2. Thesystem of claim 1 wherein said disposable piece of previously rolledadhesive member is a piece of adhesive tape.
 3. The system of claim 1wherein said disposable piece of previously rolled adhesive member isflexible.
 4. A system for protecting inside surfaces of a needle guide,which is coupled to an endoscope imaging device, from contaminationentering through a needle exit hole of the needle guide, the systemcomprising: a needle guide configured to be directly disposed on,supported by and directly coupled to and partially enshroud an exteriorsurface of an endoscope imaging device, having a distal endoscope endconfigured to be inserted inside a body cavity of a human and a proximalendoscope end configured to remain outside the body cavity; said needleguide having a distal end and a proximal handle end and a needle exithole therein distal of said proximal handle end, said needle exit holeis configured to allow a needle or cannula which is inserted into theneedle guide to exit the needle guide; said distal end disposed inproximity to said distal endoscope end; and a rollable adhesive membraneportion securely attached to an external needle guide surface of saidneedle guide around a periphery of said needle exit hole, where saidrollable adhesive membrane portion extends completely over andcompletely covers said needle exit hole and said rollable adhesivemembrane portion is not configured to contact a portion of an endoscopeimaging device; and said rollable adhesive membrane portion securelyattached to an engagement zone, having an engagement zone radialdimension, which is larger than said needle exit hole radial dimension,of an external needle guide surface of said needle guide around aperiphery of said needle exit hole.
 5. The system of claim 4 whereinsaid rollable adhesive membrane portion is a piece of tape removed froma roll of adhesive tape.
 6. A method of protecting an inside of a needleguide comprising the steps of: providing an endoscope imaging devicehaving a distal endoscope end configured to be inserted inside a bodycavity of a human and a proximal endoscope end configured to remainoutside the body cavity; providing a disposable sheath disposed aboutsaid endoscope imaging device; providing a needle guide configured to bedisposed on said disposable sheath, supported by and indirectly coupled,through said disposable sheath, to and partially enshroud an exteriorsurface of an endoscope imaging device, said needle guide having adistal end and a proximal handle end and a needle exit hole thereindistal of said proximal handle end, said needle exit hole is configuredto allow a needle or cannula which is inserted into the needle guide toexit the needle guide while inside a body cavity; said distal enddisposed in proximity to said distal endoscope end; providing a roll ofmembrane, securely attaching to an external needle guide surface of saidneedle guide around a periphery of said needle exit hole, a portion ofsaid roll, where said portion of said roll extends radially beyond andcompletely covers said needle exit hole and does not contact a portionof said endoscope imaging device; said portion of said roll securelyattached to an engagement zone, having an engagement zone radialdimension, which is larger than said needle exit hole radial dimension,of an external needle guide surface of said needle guide around aperiphery of said needle exit hole; wherein said step of securelyattaching comprises the step of providing an adhesive, disposed betweenand coupling said needle guide and said portion of said roll; andwherein a layered configuration exists beginning with the exteriorsurface of said endoscope imaging device, said disposable sheath, thenthe needle guide, then finally the portion of said roll.
 7. The methodof claim 6 wherein said steps of providing a roll of membrane andproviding an adhesive are accomplished by a single step of providing aroll of adhesive membrane.
 8. The method of claim 7 wherein said step ofproviding a roll of adhesive membrane comprises providing a roll ofadhesive tape.
 9. A method of protecting an inside of a needle guidecomprising the steps of: providing an endoscope imaging device having adistal endoscope end configured to be inserted inside a body cavity of ahuman and a proximal endoscope end configured to remain outside the bodycavity; providing a disposable sheath disposed about said endoscopeimaging device; providing a needle guide configured to be directlydisposed on, supported by and directly coupled to and partially enshroudan exterior surface of an endoscope imaging device, said needle guidehaving a distal end and a proximal handle end and a needle exit holetherein distal of said proximal handle end, said needle exit hole isconfigured to allow a needle or cannula which is inserted into theneedle guide to exit the needle guide while inside a body cavity; saiddistal end disposed in proximity to said distal endoscope end; providinga disposable piece of flexible adhesive membrane securely attached to anexternal needle guide surface of said needle guide around a periphery ofsaid needle exit hole, where said disposable piece of flexible adhesivemembrane extends radially beyond and completely covers said needle exithole and does not contact a portion of said endoscope imaging device;and said disposable piece of flexible adhesive membrane securelyattached to an engagement zone, having an engagement zone radialdimension, which is larger than said needle exit hole radial dimension,of an external needle guide surface of said needle guide around aperiphery of said needle exit hole; and wherein said disposable piece offlexible adhesive membrane is coupled to an exterior portion of saidsheath and a layered configuration exists beginning with the exteriorsurface of said endoscope imaging device, said disposable sheath, thenthe needle guide, then the adhesive and finally the disposable piece offlexible adhesive membrane.
 10. The method of claim 9 wherein said stepof providing a disposable piece of flexible adhesive membrane comprisesremoving a piece of adhesive tape from a roll of adhesive tape.